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Sodium BicarbonateNCT06098794

Effect of Sodium Bicarbonate on Exercise Performance

A study testing Sodium Bicarbonate in people with Sodium Bicarbonate, run by Faculdade de Motricidade Humana at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a randomized, double-blind, placebo controlled, crossover trial. The study aimed to assess the effect of sodium bicarbonate on the ability to perform a repeated sprint task by female football players. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sodium Bicarbonate
What is being tested?
Sodium Bicarbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 sitePortugal
Study dates
15 Oct 2021to 27 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Football players
  • Regularly training with a weekly microcycle consisting of 3 to 5 training sessions and 1 game at the weekend
  • Able to provide informed consent

Who cannot join

  • Injury occurrence in the month previous to data collection
  • Ergogenic supplements consumption in the month previous to data collection
  • Having known intolerance to sodium bicarbonate

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Faculty of Human Kinetics

    Lisbon, 1495-002 Cruz-Quebrada

Other trials in Portugal

About this study

Official title: The Effects of Sodium Bicarbonate Supplementation on Intense Exercise Performance

This was a randomized, double-blind, placebo controlled, crossover trial. The study aimed to assess the effect of sodium bicarbonate on the ability to perform a repeated sprint task by female football players. The researches hypothesis was that sodium bicarbonate increases the ability to remove lactic acid from muscle cells reducing its intracellular accumulation and increasing energetic efficiency resulting in the increase of peak power output, mean power output, or total work or in the decrease of the sprint decrement in each set of the repeated sprints task.

Read the detailed description

Experimental design: The study consisted of a randomized, double-blind, controlled, crossover trial where 11 female football players performed, in a randomized order, two repeated sprints tasks in a cycle ergometer, after having ingested either sodium bicarbonate (SB) or placebo (PL). Body composition of the athletes was characterized by bioelectrical impedance analysis with a single frequency (50 kHz) device (BIA 101 Anniversary, Akern, Florence, Italy) before the exercise sessions. Data collection was separated by a period of at least one week within a period of time not exceeding one month and performed at the same time of the day for each participant. Data regarding performance, blood lactate accumulation, pulmonary gas exchange, heart rate (HR), muscle oxygenation and neuromuscular fatigue were collected during these two sessions.

Supplementation protocol: The participants ingested capsules containing 0.3 g/kg of body weight of SB or cellulose as PL divided into two doses. The first intake (0.2 g/kg) occurred 2 h before the beginning of the protocol, and the second (0.1 g/kg) occurred 1 h later. Possible gastrointestinal symptoms associated with supplement ingestion were controlled with a questionnaire based on the questionnaire applied by Miller et al. (2016).

Repeated sprints protocol: The RSA protocol was performed in a cycle ergometer (Monark Ergomedic 894 E, Monark Exercise AB, Vansbro, Sweden) and was composed of 3 sets of 6 sprints with 6 s duration with a workload of 4% of the body mass. Repetitions were separated by 24 s of active recovery, and participants were conceded 5 min of passive recovery to rest between sets. The protocol was preceded by a 5-min warm-up in which athletes pedalled at a speed of 60 to 70 rpm.

Performance Measurements: Performance was evaluated by monitoring peak power output, mean power output, total work and the sprint decrement in each set of the two repeated sprints task.

Blood lactate accumulation: Lactate concentration was assessed (Lactate Pro 2, KDK Corporation, Kyoto, Japan) in capillary blood from the ear lobe before the beginning of each protocol, 1 min after the end of each set, and at min 1 and every 2 min after the tasks were completed, until the value started to decrease. At the end of the tasks, the maximal values achieved were considered for analysis.

Pulmonary gas exchange and heart rate: Oxygen uptake, carbon dioxide production and ventilation (VO2, VCO2, VE, respectively) were measured breath-by-breath, during the protocol, using a gas analyser (MetaMax 3B, Cortex Biophysik, Leipzig, Germany). Heart rate was continuously evaluated using an HR monitor (H7, Polar Electro Oy, Kempele, Finland). The integral of VO2 (L) and VCO2 (L) and the maximum 6-s moving average of relative VO2 (mL/kg.min), VE (L/min) and HR (bpm) were calculated for each set.

Muscle oxygenation: Throughout the protocol, oxygenated (O2Hb) and deoxygenated haemoglobin (HHb) were continuously monitored with a near-infrared spectroscopy device (Niro-200NX, Hamamatsu Phototonics, Hamamatsu, Japan) according with the manufacturer specifications. The integrals of O2Hb and HHb were calculated for each set of the protocol.

Neuromuscular fatigue assessment: Athletes executed a countermovement jump (CMJ) in a contact mat (Chronojump BoscoSystem, Software Version 2.2.0, Barcelona, Spain) before and after the exercise protocol, accessing values of jump height (JH). Three jumps were performed, separated by 30 s of rest, and the best jump was considered for analysis.

Data analysis: Power and sample calculations (G-Power, Version 3.1.9.2, Düsseldorf, Germany) were based on an effect size of 0.88 (McNaughton et al., 1997) for total work performed in the sprints, a power of 0.85 and a significance of 0.05. After the recruitment process, 12 athletes volunteered to participate in the study. One volunteer withdrew due to injury, leading to a sample size of 11 athletes. Statistical analysis was performed using the Statistical Package for the Social Sciences (IBM Corp, SPSS v27.0, Armonk, NY, USA) and R software (v4.2.0, Open-Source Code, General Public License). Normal distribution and sphericity were tested using Shapiro-Wilk's and Mauchly's tests, respectively. For variables with normal distribution, data was analysed using a two-way analysis of variance (ANOVA). Whenever a statistical significance was observed in the two-way ANOVA, post-hoc paired comparisons were performed with the Bonferroni correction. Statistical significance was set at p < 0.05. If normal distribution was not verified, the nparLD module of the R software was used to perform a non-parametric two-way ANOVA-type test and if any significant result was observed, a Friedman test and the post-hoc paired comparisons with the Bonferroni correction as well as a Wilcoxon test were performed. Statistical significance was adjusted according with the number of tests performed for each factor.

Being tested
Sodium Bicarbonate, Placebo
Keywords
Ergogenic Dietary Supplement, Repeated Sprints Performance, Muscle Oxygenation, Oxygen Consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium BicarbonateDietary supplement

    Capsules containing 0.3 g/kg of body weight of sodium bicarbonate were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later.

  • PlaceboDietary supplement

    Capsules containing 0.3 g/kg of body weight of celulose were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later.

Study groups in NCT06098794
Study groupRoleWhat they receive
Sodium Bicarbonate - PlaceboExperimentalFirst exercise performance assessment after ingesting sodium bicarbonate. Second exercise performance assessment after ingesting placebo
Receives: Dietary Supplement: Sodium Bicarbonate; Dietary Supplement: Placebo
Placebo - Sodium BicarbonateExperimentalFirst exercise performance assessment after ingesting placebo. Second exercise performance assessment after ingesting sodium bicarbonate
Receives: Dietary Supplement: Sodium Bicarbonate; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak power output

    Watt

    Measured: 3 minutes through each set of the repeated sprints tasks

  2. Mean power output

    Watt

    Measured: 3 minutes through each set of the repeated sprints tasks

  3. Total Work

    Joule

    Measured: 3 minutes through each set of the repeated sprints tasks

  4. Sprint Decrement

    percentage of power decrease

    Measured: 3 minutes through each set of the repeated sprints tasks

Secondary outcomes (8)
  1. Countermovement jump height

    cm

    Measured: Before and after each repeated sprints tasks

  2. Lactate accumulation

    mmol.L-1

    Measured: Before the repeated sprints tasks, between sets of the repeated sprints tasks, immediatly after the repeated sprints tasks, 2 minutes after the repeated sprints tasks

  3. Oxygen uptake

    mL/kg.min

    Measured: 3 minutes through each set of the repeated sprints tasks

  4. carbon dioxide production

    Total L

    Measured: 3 minutes through each set of the repeated sprints tasks

  5. Ventilation

    L/min

    Measured: 3 minutes through each set of the repeated sprints tasks

  6. Heart rate

    bpm

    Measured: 3 minutes through each set of the repeated sprints tasks

  7. Changes in muscle oxygenated haemoglobin

    Absorvance relative to rest obtained by Near InfraRed Spectroscopy

    Measured: 3 minutes through each set of the repeated sprints tasks

  8. Changes in muscle deoxygenated haemoglobin

    Absorvance relative to rest obtained by Near InfraRed Spectroscopy

    Measured: 3 minutes through each set of the repeated sprints tasks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start15 Oct 2021
  3. Primary completion27 Apr 2022
  4. Study completion27 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06098794
Sponsor's protocol ID
RepSprintsSodiumBicarbonate
Status last verified
Oct 2023
First submitted
6 Oct 2023
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sodium Bicarbonate in people with Sodium Bicarbonate, run by Faculdade de Motricidade Humana at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak power output (time frame: 3 minutes through each set of the repeated sprints tasks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.

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